Trial Outcomes & Findings for Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants (NCT NCT03694613)

Results Overview

Normal Range approximately 6,000 - 30,000 cell/mm3.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

65 participants

Primary outcome timeframe

Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

Results posted on

2021-08-10

Participant Flow

Subjects were recruited at the Neonatal Intensive Care of the University of Texas Medical Branch, Galveston, Texas.

We included 65 PI \<34 weeks, who were screened for EOS and admitted to the NICU (June 2019 to June 2020). Infants with known lethal chromosomal or congenital anomalies were excluded.

Participant milestones

Participant milestones
Measure	Placental/Umbilical Cord Blood Samples Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Placental/Umbilical Cord Blood sample: After an infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using a vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
Overall Study STARTED	65
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Placental/Umbilical Cord Blood sample will be collected after delivery from every participant. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
Age, Continuous	32.15 Weeks STANDARD_DEVIATION 2.21 • n=93 Participants
Sex: Female, Male Female	27 Participants n=93 Participants
Sex: Female, Male Male	38 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	10 Participants n=93 Participants
Race (NIH/OMB) White	41 Participants n=93 Participants
Race (NIH/OMB) More than one race	12 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	65 participants n=93 Participants
Birth weight	1853 grams STANDARD_DEVIATION 519 • n=93 Participants

PRIMARY outcome

Timeframe: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

Normal Range approximately 6,000 - 30,000 cell/mm3.

Outcome measures

Outcome measures
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
White Blood Cell Count (WBC) (1)	8257 ratio of cells/mm3 Standard Deviation 2966

PRIMARY outcome

Timeframe: Completed during the first 6 hours after birth. This sample is going to be taken directly from the participant.

Population: Infant blood taken from 65 subjects after birth

Normal Range: 6.000 - 30.000 cell/mm3.

Outcome measures

Outcome measures
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
White Blood Cell Count (WBC) (1) INFANT BLOOD	7055 ratio of cells/mm3 Standard Deviation 12400

PRIMARY outcome

Timeframe: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

Normal Range of I/T ratio: \<0.2.

Outcome measures

Outcome measures
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
I/T Ratio (Immature/Total Immature Neutrophil).I/T Ratio Was Calculated by Dividing Immature White Cell Count Total White Cell Count	0.09 Ratio of Immatures/Total neutrophils Standard Deviation 0.13

PRIMARY outcome

Timeframe: Completed during the first 12 hours after birth. This sample is going to be taken directly from the participant.

Normal Range: \<0.2

Outcome measures

Outcome measures
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
I/T Ratio (Immature/Total Immature Neutrophil Ratio) INFANT BLOOD	0.12 Immatures/Total neutrophils ratio Standard Deviation 0.13

PRIMARY outcome

Timeframe: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

Normal Range: \< 10,000 ng/mL

Outcome measures

Outcome measures
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
CRP (C-Reactive Protein)(1)	413 ng/mL Standard Deviation 1229

PRIMARY outcome

Timeframe: Completed during the first 6 hours after birth. This sample was taken directly from the participant.

Normal Range: \<10.000ng/mL

Outcome measures

Outcome measures
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
CRP (C-Reactive Protein)(2) INFANT BLOOD	785 ng/mL Standard Deviation 1846

PRIMARY outcome

Timeframe: Completed during the first 30 minutes after birth. This sample is going to be taken from the discarded Placental/umbilical blood cord.

Normal Range: 0-10.2 pg/ml

Outcome measures

Outcome measures
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
IL-6 (1) PUCB	61.45 ng/mL Standard Deviation 392.7
IL-6 (1) INFANT BLOOD	45.36 ng/mL Standard Deviation 182.3

PRIMARY outcome

Timeframe: Completed during the first 6hours after birth. This sample is going to be taken directly from the participant.

Population: Blood was taken from all 65 Infants from placenta and from baby 6 hours after birth

Normal Range: \<100 pg/mL

Outcome measures

Outcome measures
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
IL-6 (Interleukin-6) INFANTS BLOOD	45.36 pg/mL Standard Deviation 182.3

PRIMARY outcome

Timeframe: Within 30 minutes after delivery

Population: PUBC from all 65 subjects recruited

Blood was taken from PUBC after delivery

Outcome measures

Outcome measures
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
Procalcitonin PUBC	185.9 pg/mL Standard Deviation 374

PRIMARY outcome

Timeframe: Procalcitonin Level was measured in the blood from placenta and in Infant's Blood (within 6 hours)

Procalcitonin levels

Outcome measures

Outcome measures
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
Procalcitonin Level Was Measured in the Blood From Placenta and From the Baby Within 6 Hours After Birth	131.4 pg/mL Standard Deviation 411.7

PRIMARY outcome

Timeframe: Blood sample drawn from placenta and from baby within 6 hours after birth.

Population: 65 out of 65 subjects were reported to have NEGATIVE blood cultures

Normal Range: Blood Culture Negative

Outcome measures

Outcome measures
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
Number of Participants With Negative Blood Culture From Blood Drawn From Placenta and From Baby Within 6 Hours After Birth	65 Participants

PRIMARY outcome

Timeframe: First 30 min after birth

Presepsin level was measured in the blood drawn from placenta and from the baby within 6 hours after birth

Outcome measures

Outcome measures
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
Presepsin- PUBC	4.6 ng/mL Standard Deviation 1.6

PRIMARY outcome

Timeframe: First 30 min after birth

Levels of presepsin

Outcome measures

Outcome measures
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
Presepsin-Infant's Blood	5.3 ng/mL Standard Deviation 2

PRIMARY outcome

Timeframe: first 2 hours after birth

Population: A negative blood culture indicates no infection

Blood is taken from infants after birth

Outcome measures

Outcome measures
Measure	Placental/Umbilical Cord Blood Sample n=65 Participants Study Group: Placental/Umbilical Cord Blood sample will be collected after delivery from every participant recruited. Plancental/Umbilical Cord Blood sample: After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
Number of Participants With a Negative Blood Culture	65 Participants

Adverse Events

Placental/Umbilical Cord Blood Sample

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sergio Lerma

Fundacion Santa Fe, Bogotá, Colombia

Phone: +57 3017752726

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place